Abstract：
BACKGROUND: Venoactive drugs (VADs) based on Vitis vinifera extract are widely used in Korea. However, studies on the clinical effects and head-to-head comparisons with other groups of VADs are limited. This trial aimed to evaluate whether Vitis vinifera seed extract was noninferior to the micronized purified flavonoid fraction (MPFF) in relieving venous symptoms and improving quality of life in patients with chronic venous disease.
METHODS: In this double-blind prospective randomized trial, patients from 13 hospitals, who were diagnosed with venous incompetence by duplex ultrasound and classified as clinical class 1, 2, or 3 in the Clinical, Etiological, Anatomical, and Pathophysiological classifications were enrolled. The primary outcome was the change in the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) score at 8 weeks from baseline. Secondary outcomes included changes in the Aberdeen Varicose Vein Questionnaire, visual analog scale, and Venous Clinical Severity Score at 4 and 8 weeks from baseline. Moreover, the change in leg circumferences was measured at 8 weeks and compared to baseline.
RESULTS: In total, 303 patients were enrolled and randomly assigned to receive either Vitis vinifera seed extract (n = 154) or MPFF (n = 149). The CIVIQ-20 scores at 8 weeks were significantly reduced compared to those at baseline in both groups. No significant intergroup difference in the change of CIVIQ-20 at 8 weeks from baseline was observed (-8.31 ± 14.63 vs. -10.35 ± 14.38, P = 0.29, 95% confidence interval -1.65 to 5.72). The lower limit of the 95% confidence interval was within the predefined noninferiority margin of 6.9. Furthermore, the Aberdeen Varicose Vein Questionnaire, visual analog scale, and Venous Clinical Severity Score scores significantly decreased at 4 and 8 weeks after randomization compared with baseline in both groups. No significant differences were observed in the reduction of each score between groups. The calf circumference measured at 8 weeks was significantly reduced compared to that at baseline in patients receiving Vitis vinifera seed extract.
CONCLUSIONS: Vitis vinifera seed extract was noninferior to MPFF in relieving venous symptoms and improving the quality of life in patients with chronic venous disease.
METHODS: In this double-blind prospective randomized trial, patients from 13 hospitals, who were diagnosed with venous incompetence by duplex ultrasound and classified as clinical class 1, 2, or 3 in the Clinical, Etiological, Anatomical, and Pathophysiological classifications were enrolled. The primary outcome was the change in the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) score at 8 weeks from baseline. Secondary outcomes included changes in the Aberdeen Varicose Vein Questionnaire, visual analog scale, and Venous Clinical Severity Score at 4 and 8 weeks from baseline. Moreover, the change in leg circumferences was measured at 8 weeks and compared to baseline.
RESULTS: In total, 303 patients were enrolled and randomly assigned to receive either Vitis vinifera seed extract (n = 154) or MPFF (n = 149). The CIVIQ-20 scores at 8 weeks were significantly reduced compared to those at baseline in both groups. No significant intergroup difference in the change of CIVIQ-20 at 8 weeks from baseline was observed (-8.31 ± 14.63 vs. -10.35 ± 14.38, P = 0.29, 95% confidence interval -1.65 to 5.72). The lower limit of the 95% confidence interval was within the predefined noninferiority margin of 6.9. Furthermore, the Aberdeen Varicose Vein Questionnaire, visual analog scale, and Venous Clinical Severity Score scores significantly decreased at 4 and 8 weeks after randomization compared with baseline in both groups. No significant differences were observed in the reduction of each score between groups. The calf circumference measured at 8 weeks was significantly reduced compared to that at baseline in patients receiving Vitis vinifera seed extract.
CONCLUSIONS: Vitis vinifera seed extract was noninferior to MPFF in relieving venous symptoms and improving the quality of life in patients with chronic venous disease.
摘要：
背景：基于葡萄提取物的静脉活性药物（VAD）在韩国被广泛使用。然而,关于VAD的临床效果以及与其他组的正面比较的研究有限.该试验旨在评估葡萄种子提取物在缓解慢性静脉疾病（CVD）患者的静脉症状和改善生活质量方面是否不劣于微粉化纯化的类黄酮成分（MPFF）。
方法：在这项双盲前瞻性随机试验中，13家医院的病人,通过双工超声诊断为静脉功能不全，并在临床中将其分类为临床1、2或3级，病因学,解剖学,并纳入病理生理学分类。主要结果是慢性静脉疾病生活质量问卷（CIVIQ-20）评分在8周时从基线的变化。次要结局包括阿伯丁静脉曲张问卷（AVVQ）的变化，视觉模拟量表(VAS)，和静脉临床严重程度评分（VCSS）在4周和8周从基线。此外，在第8周时测量了腿围的变化,并与基线进行了比较.
结果：总计，纳入303名患者，并随机分配接受葡萄种子提取物（n=154）或MPFF（n=149）。与基线相比，两组在8周时的CIVIQ-20评分均显着降低。从基线开始8周时，CIVIQ-20的变化在组间没有显着差异（-8.31±14.63vs.-10.35±14.38，P=0.29，95%置信区间[CI]-1.65至5.72）。95%CI的下限在6.9的预定义非劣效性范围内。此外，AVVQ,VAS,与基线相比，两组在随机分组后4周和8周VCSS评分均显著下降。组间各评分的降低没有观察到显著差异。与接受葡萄种子提取物的患者的基线相比，在8周时测量的小腿周长显着降低。
结论：葡萄籽提取物在缓解静脉症状和改善CVD患者生活质量方面不劣于MPFF。
方法：在这项双盲前瞻性随机试验中，13家医院的病人,通过双工超声诊断为静脉功能不全，并在临床中将其分类为临床1、2或3级，病因学,解剖学,并纳入病理生理学分类。主要结果是慢性静脉疾病生活质量问卷（CIVIQ-20）评分在8周时从基线的变化。次要结局包括阿伯丁静脉曲张问卷（AVVQ）的变化，视觉模拟量表(VAS)，和静脉临床严重程度评分（VCSS）在4周和8周从基线。此外，在第8周时测量了腿围的变化,并与基线进行了比较.
结果：总计，纳入303名患者，并随机分配接受葡萄种子提取物（n=154）或MPFF（n=149）。与基线相比，两组在8周时的CIVIQ-20评分均显着降低。从基线开始8周时，CIVIQ-20的变化在组间没有显着差异（-8.31±14.63vs.-10.35±14.38，P=0.29，95%置信区间[CI]-1.65至5.72）。95%CI的下限在6.9的预定义非劣效性范围内。此外，AVVQ,VAS,与基线相比，两组在随机分组后4周和8周VCSS评分均显著下降。组间各评分的降低没有观察到显著差异。与接受葡萄种子提取物的患者的基线相比，在8周时测量的小腿周长显着降低。
结论：葡萄籽提取物在缓解静脉症状和改善CVD患者生活质量方面不劣于MPFF。
